Historically, interpretation and diagnosis of mammograms and other medical image analysis has been performed using hardcopy x-ray films viewed on an alternator that typically allows x-ray films to be illuminated and masked for diagnostic viewing. Newer technology allows a radiologist or other medical professional to view mammograms and other diagnostic images electronically on high-resolution monitors. These images can also be digitally stored and transmitted across secure networks for archiving or review by other professionals.
A radiologist generally begins his or her review process by reviewing a patient's background information relevant to a radiology study, such as a patient's name, age, and any applicable medical conditions or risk factors. After reviewing the background information, the radiologist views multiple images created by radiological, X-ray, computed tomography (CT), ultrasound, magnetic resonance imaging (MRI), tomosynthesis, or other imaging technique of the patient's breast, or other organ, and dictates or uses a computerized information system to track findings, create reports, and make recommendations for future examinations. Such findings can include information pertaining to tissue density, the presence of masses, cysts, calcifications and other abnormalities, or any other breast tissue characteristics.
While there has been recent debate regarding the frequency at which women should undergo regular mammogram screenings, and at what age such screenings should begin, it is unlikely that the relatively quick and typically effective practice of mammography screening for breast cancer will disappear completely. Accordingly, there will continue to be a need for radiologists to view and interpret the images generated from patient examinations and screenings. Because the risk of breast cancer threatens the lives of many women, especially those over age 40, radiologists are often inundated with large numbers of mammogram images that must be viewed and, if abnormalities are present, categorized in order to determine if further examination is required. The developments in advanced patient imaging techniques, such as MRI, are also increasing the raw number of images that a radiologist can review. Therefore, there is an ongoing need to improve the speed and efficiency of the radiologist's review of the mammogram images, without sacrificing accuracy, and with the smallest number of false-positive diagnoses. Additionally, given that mammograms are taken periodically, such as annually or biannually, once screening begins for a particular woman, there is also a need to manage, track and analyze data taken over a period of years or decades for a woman.
One commercially available computerized mammography information system (MIS) in use by radiologists to review patient images is the PenRad Mammography Information System, which is able to electronically track abnormalities, generate statistics, and provide patient correspondence. The PenRad™ system is described in copending U.S. patent application Ser. Nos. 12/625,910 and 12/625,898, each filed on Nov. 25, 2009, and incorporated by reference in their entireties, and is available from PenRad. This system provides for the digital correlation of patient data related to a mammography or other diagnostic imaging procedure.
Legislation has mandated that mammography facilities track positive mammography findings and correlate such findings with biopsy results, maintain statistics for mammography medical outcome and analysis audits on each physician, and provide direct written notification to all patients of their exam results. The generation and correlation of this data is maintained locally by each medical center for each patient.
One system for categorizing this information is the Breast Imaging-Reporting and Data System (BI-RADS) published by the American College of Radiology (ACR). BI-RADS provides a system of mammography assessment categories in the form of standardized codes assigned by a radiologist during or after the viewing and interpretation of a medical image. BI-RADS allows for concise and unambiguous understanding of patient records between multiple radiologists and medical facilities. Consequently, a large number of mammogram images, biopsy results, and diagnosis statistics are potentially available in a patient-anonymous format, in compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA).
Recently, Digital Imaging and Communications in Medicine (DICOM) systems have become the accepted format for medical imaging systems. This format provides for the distribution and viewing of medical studies and images across a variety of platforms. The use of DICOM has, among other things, enabled industry compatibility and improved workflow efficiency between imaging and other information systems located in various healthcare environments. Currently, the DICOM standard is an 18-part publication, PS 3.1-2008 through PS 3.18-2008 describing a standard for digital imaging and communications in medicine developed by the American College of Radiology (ACR) and the National Electrical Manufacturers Association (NEMA) which is hereby incorporated by reference in its entirety. Among other elements, the DICOM standard provides a method of uniquely numbering any image or other information object to facilitate the unambiguous identification of images or information objects as they are viewed or manipulated in a system or transported across a network.